510(k) Report

510(k) · Cleared

Cleared

Sterling IF Screw Eyelet, Model CID3936 and Sterling Cross-Pin Eyelet, Model CID3937

K063584510(k) TraditionalCleared May 9, 2007159-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Regeneration Technologies, Inc. · HWC Screw, Fixation, Bone

Cleared on May 9, 2007 as substantially equivalent to K060253 (Regeneration Technologies, Inc., 2006) after a 159-day review. Its family tree reaches back 1 generation to 2006.

Decided
May 9, 2007
Review
159 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K060253 (2006). No later device cites it as a predicate yet.

K060253 · Sterling Interference Screw HT, Sterling Interference Screw ST. · Regeneration Technologies, Inc. · 200620062008
K060253 · Sterling Interference Screw HT, Sterling Interference Screw ST. · Regeneration Technologies, Inc. · 20060
  1. Root · 1 generation backK060253 Sterling Interference Screw HT, Sterling Interference Screw ST.Regeneration Technologies, Inc. · 2006
  2. This deviceK063584 Sterling IF Screw Eyelet, Model CID3936 and Sterling Cross-Pin…Regeneration Technologies, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K060253Sterling Interference Screw HT, Sterling Interference Screw ST.Regeneration Technologies, Inc.2006—
0 (this device)K063584Sterling IF Screw Eyelet, Model CID3936 and Sterling Cross-Pin Eyelet, Model…Regeneration Technologies, Inc.2007—
FIG. 1 — Lineage of K063584, 2006–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K060253Sterling Interference Screw HT, Sterling Interference Screw ST.
Summary page 1
…IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253. Intended Use: This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction…
Regeneration Technologies, Inc.2006—
*—LinX HT
Named without a submission number
—
*—Sterling Interference Screw ST
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.

Indications for use as stated in the FDA summary.

More from Regeneration Technologies, Inc.

11 FDA decisions under this applicant name. See the company

  • K080418Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset IC, Rti…Regeneration Technologies, Inc. · 2008
  • K072238Bioset XCHRegeneration Technologies, Inc. · 2008
  • K072327Cancello-Pure Bone Wedge, 12MM Evans or 6MM CottonRegeneration Technologies, Inc. · 2007
  • K060180Bioset XCRegeneration Technologies, Inc. · 2006
  • K060253Sterling Interference Screw HT, Sterling Interference Screw ST.Regeneration Technologies, Inc. · 2006

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K063584 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063584: Sterling IF Screw Eyelet, Model CID3936 and Sterling Cross-Pin Eyelet, Model CID3937.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063584

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026